GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect in a medical device that may prolong procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GA Health Company Limited is recalling 6,470 units of Andorate Disposable Endoscope Valves (Product Code: GAR004). The recall affects specific lot numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, and 20032503. The products were distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
The recall was initiated because the suction button on the valves is reported to be sticky and/or broken during or after a procedure. This defect may cause the medical procedure to be prolonged. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or replacement. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 6,470
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 20040201
- 20081925
- 19111119
- 20021928
- 20022682
- 20022678
- 20030406
Distribution
Part of a larger recall action
This product is one of 11 recalled by GA HEALTH COMPANY LIMITED under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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